Gabriela Biedebach
Glendora,NJ
Summary
Quality-driven Compliance Specialist with 5.5 years of expertise in the Pharmaceutical Industry.
Renowned for enhancing workflow efficiencies & reducing non-compliance through QMS strategies with exceptional analytical thinking in continuous improvement initiatives.
Familiar with the requirements needed for maintaining, documenting, and reporting of investigative processes (Deviations, CAPA, Abort/Invalid, Out of Specifications, Risk Assessments, Root Cause Analysis).
Organized and dependable candidate willing to take on and prioritize responsibilities to meet team goals with a positive attitude.
Overview
6
6
years of professional experience
Work History
QC Compliance Specialist
Dechra
09.2023 - Current
- Conducts 95% of the QC Microbiology Department's investigative reports and risk assessments to address potential areas of non-compliance and recommended corrective actions within a 30 business day period.
- Serves as a point of contact for employees seeking guidance on compliance matters, instilling confidence in the organization''s commitment to 100% regulatory adherence.
- Reduced potential QC Data-Integrity issues by 20% by evaluating existing policies, identifying areas for improvement, and recommending revisions as needed to integrate compliance considerations into daily business operations seamlessly.
- Conduct periodic compliance internal audits, reviews and prepared documentation and records for upcoming audits and inspections to identify areas of improvement.
Microbiology Analyst III
Med-Pharmex (A Dechra Company)
09.2018 - Current
- Conducted 25% of the all microbiological testing (Cylinder-Plate Assay, Microbial Limit Testing, & Turbidimetric Assay) on various samples, ensuring timely completion of projects and meeting clients'' needs while maintaining high-quality standards throughout the entire sample lifecycle.
- Led & Supported junior analysts & new-hirers through mentorship, and training sessions in laboratory procedures, ensuring a seamless integration into the team and fostering a culture of continuous learning.
- Contributed to successful audits by diligently following established protocols and maintaining detailed records of all laboratory processes.
- Managed 50% inventory of lab supplies, ensuring adequate stock levels to prevent delays in project timelines.
Education
Bachelor of Science - Biology
University of La Verne
La Verne, CA05.2018
Skills
- Good Manufacturing Practices
- Quality Control Compliance knowledge
- Investigation techniques & expertise
- Attention to Detail
- Continuous Improvement Initiatives
- Analytical Thinking
- Internal Auditing
Timeline
QC Compliance Specialist
Dechra
09.2023 - Current
Microbiology Analyst III
Med-Pharmex (A Dechra Company)
09.2018 - Current
Bachelor of Science - Biology
University of La Verne
Similar Profiles
Hans NuytsHans Nuyts
Country Manager at DechraCountry Manager at Dechra
SAMANTHA PENLEYSAMANTHA PENLEY
Territory Sales Manager at Dechra Veterinary ProductsTerritory Sales Manager at Dechra Veterinary Products
Natasha GleesonNatasha Gleeson
Territory Manager at Dechra Veterinary Products LimitedTerritory Manager at Dechra Veterinary Products Limited